GEM recalls specific PAK cartridges for Premier 5000 devices that may cause repeated process errors during warm-up, requiring frequent cartridge replacements and delaying test results.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
GEM is recalling certain PAK cartridges for its Premier 5000 devices after customers reported repeated errors during warm-up. These errors can cause the device to eject the cartridge multiple times, requiring frequent replacements and potentially delaying patient test results.
The PAK cartridges may experience repeated 'Process Control Solution Not Detected' errors during warm-up, causing the device to eject the cartridge multiple times. This requires inserting a new cartridge each time, which can prolong test turnaround times and potentially delay patient results.
Users of GEM Premier 5000 devices with the specific PAK cartridges listed in the recall. Laboratory staff and healthcare providers who run tests using these cartridges are most at risk of delays in patient results.
Check for the part number 00055360010 on the cartridge. The recall includes specific production lots listed in the record, such as 251023N through 251231L.
Look for the lot numbers listed in the recall (e.g., 251023N, 251103I) on the cartridge's packaging or label.
No, the recall does not require immediate discontinuation. The cartridges can continue to be used but may cause repeated errors during warm-up.
Repeated cartridge ejections may prolong test turnaround times, potentially requiring reassessment of patient management once results are available.
Check the lot number on the cartridge to see if it's affected. If it is, you may need to replace it with a new cartridge from the manufacturer.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1526-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1526-2026 from GEM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
